BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASICCARE ELECTRIC BED

    MDR report key: 4088338 · Received July 5, 2014

    Report

    Report Number
    3003463213-2014-00005
    Event Type
    Malfunction
    Date Received
    July 5, 2014
    Date of Event
    January 23, 2013
    Report Date
    June 10, 2014
    Manufacturer
    OPTIMA HEALTHCARE, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE QUALITY HISTORY, THIS KIND OF FAILURE IS LIKELY TO HAPPEN WHEN THE SIDE RAIL WAS IMPACTED DURING TRANSPORTATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE SIDE RAIL WILL NOT LATCH IN THE UP POSITION. NO INJURY REPORTED. THE CUSTOMER STATED THAT THE PIN THAT THE PULL KNOB ATTACHES TO IS TOO SHORT AND WILL NOT ALLOW THE LATCH BLOCK TO SLIDE INTO THE HOLE THAT LATCHES THE SIDE RAIL IN THE UP POSITION. THE TECHNICIAN ENTERED AN ORDER FOR A REPLACEMENT PULL KNOB KIT TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392948 BASICCARE ELECTRIC BED AC POWERED ADJUSTABLE HOSPITAL BED FNL OPTIMA HEALTHCARE, INC. 1440

    Patients

    Seq Age Sex Outcome Treatment
    1